MAUDE Adverse Event Report: ETHICON INC. VERSAPOINT ELECTRODE UNKNOWN PRODUCT; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number VERSAUNK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Cramp(s) (2193); Discomfort (2330); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: ref gynecol obstet 7:169-173.(b)(4).

Event Description

Title: versapoint in the treatment of focal intra-uterine pathology in an outpatient clinic setting.The authors described their experience with the versapoint system (ethicon) in an outpatient setting in the treatment of focal intra-uterine pathology.Between october 1998 and december 1999, 632 female patients were seen in the outpatient hysteroscopy clinic in which symptom assessment was carried out with gynaecological history, pelvic ultrasound examination and diagnostic hysterscopy.Of the 632, only 125 female patients (median age: 52.1 years; age range: 22 to 77 years) underwent the treatment using versapoint system (ethicon).Diagnostic hysteroscopy was carried out using a 1.8 mm 0 degree semi-rigid fibre telescope with a disposable sheath (versascope; gynecare).The sheath consists of an inflow channel which houses the hysteroscope and allows for infusion of saline.The outflow channel for the distension medium also serves as the operative channel for 2 mm instruments.Versapoint system (ethicon) was used for treatment during the diagnostic hysteroscopy.On activation, a steam bubble forms at the electrode tip, which upon contact with tissue causes instantaneous cellular rupture and vaporization.Reported complications included painful diagnostic hysteroscopy (n-?), procedure failed (n-15) in which 7 patients had their surgery successfully completed in a second session and 8 patients needed admission for a day-case procedure under general anesthesia, abdominal cramping (n-?) which improved immediately as the surgery ended, post operative discomfort/pain (n-?) which responded to simple analgesia and 124 patients were comfortable going home within 1 hour after the procedure but 1 patient required admission for pain control and was discharged home after an overnight stay, and heavy bleeding (n-2) which responded to oral tranexamic acid.In conclusion, the versapoint bipolar system is a versatile new technology, which is safe and well tolerated in the outpatient setting.It rduces the need for general anaesthetic in patients with benign uterine pathology.

• Brand Name: VERSAPOINT ELECTRODE UNKNOWN PRODUCT
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-GYRUS MEDICAL LTD; fortran road; cardiff
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9243111
• MDR Text Key: 167434167
• Report Number: 2210968-2019-89077
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• PMA/PMN Number: K040302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VERSAUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention